1. Standards for Pharmaceutical Applications of PAT
Don Marlowe
FDA Standards Coordinator
Office of the Commissioner
ACPS Manufacturing Subcommittee July 2004

2. ACPS Manufacturing Subcommittee July 2004
Outline
Why use consensus standards
What is ASTM
History of Committee
Committee Organization
ACPS Manufacturing Subcommittee July 2004

3. Why use the consensus standards process for PAT
Involvement of all interested parties
Balanced discussion
Due process
NTTAA
ACPS Manufacturing Subcommittee July 2004

4. ACPS Manufacturing Subcommittee July 2004
ASTM
ANSI accredited standards development organization
>100 years of experience in standards development
Recognized developer of international standards
Offices in W. Conshohocken, PA
ACPS Manufacturing Subcommittee July 2004

5. History of Development of the Committee
Winter and Spring 2003 – FDA meets with ASTM re development of a new Committee for PAT
October 2003 – PAT Committee Planning ASTM
December 1, Organizational Meeting at ASTM
January Nomination and Election of Committee Officers
February 2004 – 1st meeting of ASTM E55
Standard Terminology E 2363 published
May 2004 – 2nd Meeting of ASTM E55
ACPS Manufacturing Subcommittee July 2004

6. Committee E55 Organization
E55.01 PAT Systems Management
E55.02 PAT Systems Implementation & Practice
E55.90 Executive Subcommittee
E55.91 Terminology
ACPS Manufacturing Subcommittee July 2004

7. Describe the overall work plan and outcomes
E55 Overview of Activity
Describe the overall work plan and outcomes
E55.01 n
E55.02
Equipment
Environment
Raw Materials
People
Analytical Equip& Cntrls
Transport & Storage
Process Design
First step of primary to
final packaging
Product
Systems Infrastructure WI
Operations and Maintenance
ACPS Manufacturing Subcommittee July 2004

8. Access Information for ASTM E55
Pat Picariello
Web site -
ACPS Manufacturing Subcommittee July 2004